Adverse reactions : תופעות לוואי

4.8         Undesirable effects

Summary of the safety profile
In clinical trials with TRAVATAN, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.

Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to<1/1,000), very rare <1/10,000), or not known (frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post- marketing data with TRAVATAN.

System Organ Class              Frequency                      Adverse Reactions Immune system disorders             Uncommon        hypersensitivity, seasonal allergy Psychiatric disorders               Not known       depression, anxiety, insomnia Nervous system disorder             Uncommon        headache
Rare            dizziness, visual field defect, dysgeusia
Eye disorders                       Very common     ocular hyperaemia Common          iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation

TRA API APR22 V3                                                                           EU SmPC SEP21 Uncommon    corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis,
photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus,
visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes
Rare        iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids,
conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis,
meibomianitis, anterior chamber pigmentation,
mydriasis, asthenopia, eyelash hyperpigmentation,
eyelash thickening
Not known   macular oedema, lid sulcus deepened
Ear and labyrinth disorders   Not known   vertigo, tinnitus
Cardiac disorders             Uncommon    palpitations
Rare        heart rate irregular, heart rate decreased
Not known   chest pain, bradycardia, tachycardia,
arrhythmia
Vascular disorders            Rare        blood pressure diastolic decreased, blood pressure systolic increased, hypotension,
hypertension
Respiratory, thoracic         Uncommon    cough, nasal congestion, throat irritation and mediastinal               Rare        dyspnoea, asthma, respiratory disorder, disorders                                 oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness
Not known   asthma aggravated, epistaxis
Gastrointestinal disorders    Rare        peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth
Not known   diarrhoea, abdominal pain, nausea, vomiting
Skin and subcutaneous         Uncommon    skin hyperpigmentation (periocular), skin tissue disorders                          discolouration, hair texture abnormal, hypertrichosis
Rare        dermatitis allergic, dermatitis contact,
erythema, rash, hair colour changes,
madarosis
Not known   pruritus, hair growth abnormal
Musculoskeletal and           Rare        musculoskeletal pain, arthralgia connective tissue disorders

Renal and urinary             Not known   dysuria, urinary incontinence disorders
General disorders and         Rare        asthenia administration site conditions
Investigations                Not known   prostatic specific antigen increased 
TRA API APR22 V3                                                               EU SmPC SEP21 Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il